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Subthalamic Nucleus, Akinesia and Parkinson's Disease (GB-MOV)

Primary Purpose

Parkinson's Disease

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Bilateral subthalamic stimulation
Sponsored by
Institut National de la Santé Et de la Recherche Médicale, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Parkinson's Disease focused on measuring parkinson's disease, subthalamic nucleus, akinesia, gait initiation, neuronal activity, before STN stimulation, with STN stimulation, functional MRI

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients with Parkinson's disease candidate to DBS surgery
  • Age: 18-70 years
  • Normal brain MRI
  • Signature of the informed written consent
  • Healthy age-matched control subjects

Exclusion Criteria:

  • contraindication to MRI
  • contraindication to DBS surgery for PD patients

Sites / Locations

  • CIC-GHPSRecruiting
  • Groupe Hospitalier Pitie-SalpêtrièreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Frequency of subthalamic stimulation

Arm Description

Comparison between healthy controls and PD patients (non-operable patients or who will be operated or already operated)

Outcomes

Primary Outcome Measures

Firing rate of the subthalamic neurons
Changes in the neuronal activity of the STN before, during and after the execution of an arm movement

Secondary Outcome Measures

Evoked related potentials of the STN
Local-field potentials recordings with DBS electrodes when performing the execution of an arm movement or gait initiation
Biomechanical parameters of gait initiation
Gait initiation parameters by using a forceplate and EMG recordings

Full Information

First Posted
July 19, 2012
Last Updated
January 4, 2023
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT01682668
Brief Title
Subthalamic Nucleus, Akinesia and Parkinson's Disease
Acronym
GB-MOV
Official Title
Role of the Subthalamic Nucleus in the Control of Movement: Physiopathology of Akinesia in Parkinson's Disease.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2013 (undefined)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This program aims to understand the role of the subthalamic nucleus in the control of the movement in healthy humans and patients with Parkinson's disease, how the STN dysfunction contributes to akinesia and how the STN stimulation improves motor signs in PD patients .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
parkinson's disease, subthalamic nucleus, akinesia, gait initiation, neuronal activity, before STN stimulation, with STN stimulation, functional MRI

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Frequency of subthalamic stimulation
Arm Type
Experimental
Arm Description
Comparison between healthy controls and PD patients (non-operable patients or who will be operated or already operated)
Intervention Type
Procedure
Intervention Name(s)
Bilateral subthalamic stimulation
Primary Outcome Measure Information:
Title
Firing rate of the subthalamic neurons
Description
Changes in the neuronal activity of the STN before, during and after the execution of an arm movement
Time Frame
During surgery for bilateral STN stimulation
Secondary Outcome Measure Information:
Title
Evoked related potentials of the STN
Description
Local-field potentials recordings with DBS electrodes when performing the execution of an arm movement or gait initiation
Time Frame
3-5 days after surgery for bilateral STN stimulation
Title
Biomechanical parameters of gait initiation
Description
Gait initiation parameters by using a forceplate and EMG recordings
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
BOLD signal during fMRI
Description
Changes in the BOLD signal during fMRI with virtual imagery of movement
Time Frame
1 month before surgery
Title
real-life assessment
Description
recording using the percept device
Time Frame
1 month after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria for patients who will be operated Diagnosis of idiopathic Parkinson's disease (according to the criteria of the United Kingdom Parkinson's Disease Society Brain Bank) Age between 18 and 70; Motor complications in the form of fluctuations in motor state or dyskinesias induced by dopaminergic therapy, despite medical treatment optimum; Other medical conditions that are stable or do not interfere with the procedure proposed; Excellent responsiveness to levodopa (UPDRS motor score improvement greater than 50% in the acute levodopa test) Brain MRI without abnormality Normality of biological examinations Person who has voluntarily and informedly agreed to participate in the study (signature of a written consent) Patient with social health insurance Criteria for non-inclusion of Parkinsonian patients who will be operated Contraindication to examinations necessary for inclusion Evolutionary psychiatric pathology; Dementia(MMS<24/30); Patients with a medical condition that makes surgery dangerous neuro-surgical; Bleeding-promoting diseases and laboratory test abnormalities clotting; Existence of contraindications to MRI (cardiac or neural pacemaker, clips ferromagnetic surgeries, implants and metal objects, foreign bodies intraocular, pregnancy, claustrophobia). Taking drugs interfering with coagulation for 1 month before intervention. Persons under guardianship, curatorship or any other administrative or judicial measure deprivation of rights and liberty Selection criteria for non-operated patients Diagnosis of idiopathic Parkinson's disease (according to the criteria of the United Kingdom Parkinson's Disease Society Brain Bank); Age between 18 and 70; Other medical conditions that are stable or do not interfere with the proposed protocol; Presence of axial signs (gait and/or balance disorders) no improved by antiparkinsonian treatment Brain MRI without notable abnormality Normality of biological examinations Person who has voluntarily and informedly agreed to participate in the study (signature of a written consent) Patient with social health insurance Criteria for non-inclusion of non-operated patients Contraindication to examinations necessary for inclusion Progressive psychiatric pathology; Dementia (MMS<24/30); Existence of contraindications to MRI (cardiac or neural pacemaker, clips ferromagnetic surgeries, implants and metal objects, foreign bodies intraocular, pregnancy, claustrophobia). Persons under guardianship, curatorship or any other administrative or judicial measuredeprivation of rights and liberty Inclusion criteria for group 3 patients (already operated) Diagnosis of idiopathic Parkinson's disease (according to the criteria of the United Kingdom Parkinson's Disease Society Brain Bank); Bilateral deep brain stimulation of the subthalamic nucleus for more than 1 year Age between 18 and 70; Person who has voluntarily and informedly agreed to participate in the study (signature of a written consent) Patient with social health insurance Criteria for non-inclusion of Parkinsonian patients (already operated) Contraindication to examinations necessary for inclusion Evolutionary psychiatric pathology; Dementia(MMS<24/30); Persons under guardianship, curatorship or any other administrative or judicial measure deprivation of rights and liberty Inclusion criteria for healthy subjects Age between 18 and 70 years old Normal neurological examination Person who voluntarily and informedly agreed to participate in the study (signature of a written consent) Patient with social health insurance Criteria for non-inclusion of healthy subjects Persons under guardianship, curatorship or any other administrative or judicial measure of deprivation of rights and freedom Existence of neurological, orthopedic or psychiatric history Existence of contraindications to MRI (cardiac or neural pacemaker, ferromagnetic surgical clips, implants and metallic objects, foreign bodies intraocular, pregnancy, claustrophobia).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Laure Welter, MD, PhD
Email
marielaure.welter@icm-institute.org
First Name & Middle Initial & Last Name or Official Title & Degree
Carine Karachi, MD, PhD
Email
carine.karachi@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marie-Laure Welter, MD, PhD
Organizational Affiliation
GHPS, APHP, Paris, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
CIC-GHPS
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Laure WELTER, PH
Phone
0142162461
Email
marielaure.welter@icm-institute.org
Facility Name
Groupe Hospitalier Pitie-Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Laure Welter, MD, PhD
Email
marie-laure.welter@psl.aphp.fr

12. IPD Sharing Statement

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Subthalamic Nucleus, Akinesia and Parkinson's Disease

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